Cleared Traditional

K983731 - PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE

K983731 is an FDA 510(k) clearance for PALL DENTAL FILTRATION SYSTEM WITH INLI..., manufactured by Pall Medical. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K983731 · Pall Medical · Dental device
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Dec 1998
Decision
60d
Days
Class 1
Risk

K983731 is an FDA 510(k) clearance for the PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Pall Medical (East Hills, US). The FDA issued a Cleared decision on December 21, 1998 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pall Medical devices

FDA 510(k) Submission Details - K983731

510(k) Number K983731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1998
Decision Date December 21, 1998
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 127d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EIA Unit, Operative Dental

All 152
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K983731.
BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES
K983661 · Belmont Equipment Corp. · Jan 1999
S555 INTRAORAL DENTAL CAMERA
K983625 · Sopro · Jan 1999
PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANE
K983735 · Pall Medical · Jan 1999
SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES
K983242 · Sirona Dental Systems GmbH · Dec 1998
ERADIC-ALL
K981171 · Theratechnologies, Inc. · Dec 1998
MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT
K983847 · Germiphene Corp. · Dec 1998